Manager, Risk Management, Quality Planning & Strategy

Janssen Research and Development, L.L.C., a member of Johnson and Johnson’s Family of Companies, is recruiting for Manager, Risk Management, Quality Planning & Strategy position within the BioResearch Quality & Compliance (BRQC) Quality Planning & Strategy organization. This role will support the Pulmonary Hypertension therapeutic area. The position will ideally be located in Allschwil, Switzerland; Beerse, Belgium; Leiden, Netherlands; or High Wycombe, UK.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssen.com for more information.

The Manager, Pulmonary Hypertension Risk Management, Quality Planning & Strategy will develop and manage integrated quality plans (IQPs) to support business-critical activities such as health authority submissions to support new molecular entities or new indications for use.

• Develops and executes the Integrated Quality Plan (IQP) with guidance from the QP&S Director and/or Associate Director.

• Develops, maintains, and executes trial oversight activities for assigned trials/indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and a continued state of inspection readiness.

• Actively participates in pre-study activities, contributing to the identification of key risks in the clinical protocol and advising clinical team members on effective mitigation strategies.

• Ensures that selection of investigator sites balances benefits against potential risks and that rationale for decisions are well detailed.

• Monitors risks and mitigations during study execution. Prepares periodic reports assessing criticality to quality parameters for the trial and reviews these reports with applicable clinical team members to evaluate pre-defined areas of risk and/or identify new areas of risk.

• Responds independently to Good Clinical Practice (GCP)-related compliance inquiries from clinical team members and other departments on an ongoing basis. Liaises with other members of BRQC, as appropriate, to ensure alignment and consistency with guidance provided.

• Facilitate Quality Working Group (QWG) meetings.

• Assists/Lead in the development of materials for Stage Gate Reviews, as needed.

• Develops and executes strategy to ensure inspection readiness for the clinical trial and provides support during sponsor-monitor inspections, as needed.

• Manages escalation of significant quality issues according to company policy and SOPs and in collaboration with the clinical team and ensures timely issue resolution.

• Consults with appropriate business partners and peers within BRQC to develop and implement Corrective and Preventative Action Plans (Self-Identified, Inspection)

• Contributes to regular status reports to BRQC management, as needed.

• Consults independently on questions related to research quality and compliance from other departments and confers with other QP&S staff, and other colleagues as needed, to ensure consistent interpretation of international regulations and policy.

• Participates in QP&S, cross-BRQC Janssen, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that support key activities.

• Train/mentor peers and new employees, as needed.

  
  

A Bachelor’s degree is required, preferably in a scientific, medical, or related discipline. A minimum of eight (8) years of experience working in the health care and/or pharmaceutical industry required. Other position requirements include:

• GCP quality and/or clinical trials experience

• Experience collaborating in a cross-functional team environment

• A high degree of accuracy and attention to detail

• Excellent interpersonal, oral, and written communication skills

• Proficient in speaking and writing the country language and English

• Flexibility to respond to changing business needs

• Proficient in Microsoft Office Applications

  
  

Preferred experience includes:

• Experience with fundamentals of clinical trial risk management

• Experience with ICH guidelines

• Experience in Quality Management and Compliance functions

• Strong project management skills

• Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)

• Ability to analyze and interpret collective data to provide insights to drive decision making

• Strong knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP)

• Inspection support experience (FDA, EMA, and other inspectorates/health authorities)

  
  

General/soft skills:

• Relationship building

• Negotiation and influencing

• Conflict resolution

• Problem solving

• Strategic thinker

• Ability to create an open environment

  
  

Travel requirements:

Up to 25% primarily domestic and/or international travel